Method and system for providing an integrated analyte sensor insertion device and data processing unit

ABSTRACT

Method and apparatus for providing an integrated analyte sensor and data processing unit assembly is provided.

RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 16/443,446, filed Jun. 17, 2019, which is a continuation ofU.S. patent application Ser. No. 15/786,272, filed Oct. 17, 2017, nowU.S. Pat. No. 10,362,972, which is a continuation of U.S. patentapplication Ser. No. 14/498,895, filed Sep. 26, 2014, now U.S. Pat. No.9,808,186, which is a continuation of U.S. patent application Ser. No.13/717,501, filed Dec. 17, 2012, now U.S. Pat. No. 8,862,198, which is acontinuation of U.S. patent application Ser. No. 11/530,472, filed Sep.10, 2006, now U.S. Pat. No. 8,333,714, all of which are incorporatedherein by reference in their entireties for all purposes.

BACKGROUND

Analyte monitoring systems generally include a sensor such as asubcutaneous analyte sensor, at least a portion of which is insertedunder the skin for fluid contact with interstitial fluid, for detectinganalyte levels such as glucose levels, a transmitter (such as an RFtransmitter) in communication with the sensor and configured to receivethe sensor signals and to transmit them to a corresponding receiver unitby for example, using RF data transmission protocol. The receiver may beoperatively coupled to a glucose monitor that performs glucose relatedcalculations and data analysis.

The transmitter is in signal communication with the sensor. Generally,the sensor is configured to detect and measure the glucose levels of thepatient over a predetermined period of time, and the transmitter isconfigured to transmit data corresponding to or associated with themeasured glucose levels over the predetermined period of time forfurther analysis. To initially deploy the sensor so that the sensorelectrodes are in fluid contact with the patient's analyte fluids, aseparate deployment mechanism such as a sensor inserter or introducer isused. More specifically, the introducer includes a sharp needle shapedinserter that is configured to pierce through the skin of the patientand substantially concurrently guide the sensor through the patient'sskin so as to place at least a portion of the sensor in fluid contactwith the target biological fluid of the patient.

The inserter is typically used only during the sensor insertion process,and once the sensor is properly and accurately positioned, the inserterand the introducer are discarded. This requires a level of care as theinserter is sharp and may damage other parts of the patient's skin ifnot properly handled. Further, since the tip of the inserter has comeinto fluid contact with the patient's biological fluids, it is importantto take particular precautions in the handling of the inserter.

Further, to minimize data errors in the continuous or semi-continuousmonitoring system, it is important to properly insert the sensor throughthe patient's skin and securely retain the sensor during the time thatthe sensor is configured to detect analyte levels. Additionally, for theperiod of continuous or semi-continuous monitoring which can include,for example, 3 days, 5 days or 7 days, it is important to have thetransmitter in proper signal contact with the analyte sensor so as tominimize the potential errors in the monitored data.

In view of the foregoing, it would be desirable to have method andapparatus for providing simple, easy to handle and accurate sensorintroduction and retention mechanism for use in an analyte monitoringsystem. More specifically, it would be desirable to have method andapparatus that minimizes the number of components which the patient hasto handle, and which also reduces the number of required steps toproperly and accurately position the analyte sensor in fluid contactwith the patient's analytes.

SUMMARY

An apparatus in accordance with one embodiment of the present disclosureincludes a disposable assembly including, a housing, a data processingunit disposed in the housing, an introducer disposed within the housingand including a first portion having a sharp distal end configured forpiercing through a skin layer, where the first portion of the introduceris retained within the housing after piercing through the skin layer,and an analyte sensor including a first portion and a second portion,the first portion of the analyte sensor coupled to the first portion ofthe introducer, and the second portion of the analyte sensor coupled tothe data processing unit, where the first portion of the analyte sensoris configured for transcutaneous placement so as to be in fluid contactwith an interstitial fluid, where the second portion of the analytesensor is in electrical contact with the data processing unit prior totranscutaneous placement of the first portion of the analyte sensor, andwhere the housing, the data processing unit and the introducer areassembled to form the disposable assembly, and the data processing unitincludes an aperture through which the introducer is removable.

An integrated assembly in accordance with another embodiment includes ahousing, a data processing unit disposed within the housing, anintroducer having at least a portion disposed within the housing andincluding a first portion having a sharp distal end configured forpiercing through a skin layer, where the first portion of the introduceris retained within the housing after piercing through the skin layer,and an analyte sensor coupled to the housing, a first portion of theanalyte sensor configured for subcutaneous placement and so as to be influid contact with interstitial fluid under the skin layer, and a secondportion of the analyte sensor disposed within the housing and inelectrical communication with the data processing unit prior tosubcutaneous placement of the first portion of the analyte sensor, wherethe housing, the data processing unit, the introducer, and the analytesensor are assembled as a single disposable unit, and the dataprocessing unit includes an aperture through which the introducer isremovable.

In the manner described, within the scope of the present invention, theintegrated analyte sensor and data processing unit assembly inaccordance with the various embodiments is configured to integrate ananalyte sensor, a sensor introducer mechanism, and a data processingdevice into a single assembly which may be disposable, and which allowsfor simple and accurate sensor deployment to the desired subcutaneousposition, and that may be easily operated using one hand by the user orthe patient.

These and other features and advantages of the present invention will beunderstood upon consideration of the following detailed description ofthe invention and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a side view of the overall assembly of an integratedanalyte sensor delivery and data processing unit in accordance with oneembodiment of the present invention;

FIG. 2 illustrates a side view of the integrated analyte sensor deliveryand data processing unit of FIG. 1 without a protective guard inaccordance with one embodiment of the present invention;

FIGS. 3A-3C illustrate a perspective view, a top planar view and abottom planar view, respectively of the integrated analyte sensordelivery and data processing unit of FIG. 1 in accordance with oneembodiment of the present invention;

FIG. 4A illustrates the integrated analyte sensor delivery and dataprocessing unit of FIG. 1 with the introducer removed in accordance withone embodiment;

FIG. 4B illustrates the integrated analyte sensor delivery and dataprocessing unit without the introducer in accordance with one embodimentof the present invention;

FIG. 5A illustrates the introducer and the analyte sensor assembly withthe protective guard in accordance with one embodiment of the presentinvention;

FIGS. 5B-5C illustrate a side view and a perspective view, respectively,of the introducer and analyte sensor assembly in accordance with oneembodiment of the present invention;

FIG. 6 illustrates a block diagram of an analyte monitoring system withintegrated analyte sensor delivery and data processing unit inaccordance with one embodiment of the present invention; and

FIG. 7 illustrates a block diagram of the data processing unit of theintegrated analyte sensor delivery and data processing unit inaccordance with one embodiment of the present invention.

DETAILED DESCRIPTION

In accordance with the various embodiments of the present invention,there is provided an integrated analyte sensor delivery and dataprocessing unit for subcutaneous placement of an analyte sensor forfluid contact with an analyte of a subject for analyte monitoring, anddata processing associated with the monitored analyte levels. Morespecifically, the integrated analyte sensor delivery and data processingunit in accordance with one embodiment of the present invention providessimple, easy to use analyte sensor placement for analyte monitoring andassociated data processing without a direct line of sight visual aid,and also, which may be easily performed without the use of both hands.

FIG. 1 illustrates a side view of the overall assembly of an integratedanalyte sensor delivery and data processing unit in accordance with oneembodiment of the present invention. Referring to FIG. 1, in oneembodiment, an integrated analyte sensor delivery and data processingunit assembly 100 includes a data processing unit 101 provided on anupper surface of an adhesive patch 103 as shown. The adhesive patch 103in one embodiment is provided with an adhesive material, such as, forexample, polyester or acrylic based adhesives or any other suitablematerial which are biocompatible providing sufficient adhesive strength,on its bottom surface that is configured to securely attach the adhesivepatch 103 and the data processing unit 101 on a surface of a subjectsuch as the skin of a patient.

Referring to FIG. 1, also provided is a temperature module 105 to be inphysical contact with the surface of the subject to, among others,detect the temperature, as further discussed in further detail below inconjunction with temperature measurement section 703 of FIG. 7.Referring again to FIG. 1, the integrated sensor delivery and dataprocessing unit assembly 100 in one embodiment also includes anintroducer having an upper portion 102A and a lower portion 102B. Theupper and lower portions 102A, 102B of the introducer in one embodimentis coupled to the housing of the data processing unit 101 such that theupper portion 102A of the introducer protrudes from an upper surface ofthe data processing unit 101, while the lower portion 102B of theintroducer is configured to protrude downwardly from the bottom surfaceof the data processing unit 101 as can be seen in FIG. 1.

As shown in FIG. 1, the upper portion 102A of the introducer isconfigured to guide the user to insert the introducer through thesurface of the subject such as the skin of the patient. Thus, the upperportion 102A of the introducer in one embodiment is provided with alarger surface area (that is, for example, a larger diameter) to applyforce thereon, while the lower portion 102B of the introducer isconfigured with a sharp tip to facilitate puncturing or piercing throughthe surface of the subject such as the skin of the patient.

Additionally, in one aspect, there is provided a guard segment 104 inthe integrated analyte sensor and data processing unit assembly 100 suchthat the guard segment 104 is configured to substantially cover thelower portion 102B of the introducer. In one embodiment, the guardsegment 104 is configured as a protective needle guard so as to maintainthe lower portion 102B of the introducer in a substantially sterileenvironment prior to subcutaneous placement through the surface of thesubject such as the skin of the patient. Moreover, in one aspect, theguard segment 104 is configured to protect the sharp edge of the lowerportion 102B of the introducer from inadvertent contact with thesubject, for example, prior to the subcutaneous deployment of theanalyte sensor to avoid, for example, contamination of the lower portion102B of the introducer, or potential injury from the sharp edge of thelower portion 102B of the introducer.

More specifically, FIG. 2 illustrates a side view of the integratedanalyte sensor delivery and data processing unit of FIG. 1 without aguard segment in accordance with one embodiment of the presentinvention. Referring to FIG. 2, with the guard segment 104 of FIG. 1removed, it can be seen that in one embodiment, analyte sensor 106 isprovided in the integrated analyte sensor delivery and data processingunit 100 such that at least a portion of the analyte sensor 106 isdisposed within the lower portion 102B of the introducer.

In one embodiment, the patient or the user of the integrated analytesensor delivery and data processing unit assembly 100 removes the guardsegment 104 to expose the lower portion 102B of the introducer, andthereafter, places the entire analyte sensor delivery and dataprocessing unit assembly 100 on the surface of the subject such as theskin layer of the patient with sufficient force applied on the uppersurface of the data processing unit 101 such that the lower portion 102Bof the introducer is pierced through the skin layer of the patient.Thereafter, the introducer may be removed to detach or decouple from thedata processing unit 101 by, for example, pulling at the upper portion102A of the introducer, thereby withdrawing the introducer from thepatient and separating from the data processing unit 101, whileretaining the analyte sensor 106 (FIG. 2) in position in fluid contactwith the patient's analyte.

Referring again to FIGS. 1 and 2, in one embodiment, the bottom layer ofthe adhesive patch 103 may be provided with a protective layer (notshown) which the patient or the user of the integrated analyte sensordelivery and data processing unit assembly 100 removes (for example, bypeeling off to detach from the bottom surface of the adhesive patch 103and thus exposing the adhesive material on the bottom surface of theadhesive patch 103) prior to subcutaneously positioning the analytesensor in the patient. For example, in one embodiment, the guard segment104 may be first removed and the protective layer removed before use, oralternatively, the removal of the protective layer may be configured toremove or detach the guard segment 104 therewith. In an alternateembodiment, the protective layer and the guard segment 104 may be formedas a single integrated unit for ease of use.

FIGS. 3A-3C illustrate a perspective view, a top planar view and abottom planar view, respectively of the integrated analyte sensordelivery and data processing unit of FIG. 1 in accordance with oneembodiment of the present invention.

Referring now to FIG. 4A, the removal of the introducer is shown. Morespecifically, FIG. 4A illustrates the integrated analyte sensor deliveryand data processing unit 100 of FIG. 1 with the introducer removed, andFIG. 4B illustrates the integrated analyte sensor delivery and dataprocessing unit without the introducer in accordance with one embodimentof the present invention. That is, in one embodiment, upon placement ofthe integrated analyte sensor delivery and data processing unit assembly100 on the skin surface of the patient, for example, the patientretracts or pulls the introducer substantially at the upper portion 102Ain the direction substantially perpendicular and away from the dataprocessing unit 101 as shown by the directional arrow 401.

When the introducer is removed, in one embodiment, the entire introducerincluding the upper portion 102A and the lower portion 102B is withdrawnfrom the housing of the data processing unit 101 to completely separatefrom the data processing unit. Moreover, the portion of the analytesensor 106 is retained in the subcutaneous position so as to maintainfluid contact with the patient's analyte. In one embodiment, the housingof the data processing unit 101 is provided with a self-sealing aperture(not shown) through which the introducer may be removed, such that, whenthe introducer is withdrawn, there is no opening or aperture on the dataprocessing unit 101 housing where moisture or contaminant may compromisethe functions and operations of the data processing unit 101.Optionally, while not shown, a protective layer may be provided over theintegrated analyte sensor delivery and data processing unit 100 uponpositioning on the skin of the patient to provide protection from water,moisture or any other potential contaminants potentially damaging theintegrated analyte sensor delivery and data processing unit 100.

FIG. 5A illustrates the introducer and the analyte sensor assembly withthe protective guard, and FIGS. 5B-5C illustrate a side view and aperspective view, respectively, of the introducer and analyte sensorassembly in accordance with one embodiment of the present invention. Asshown in the Figures, the integrated analyte sensor delivery and dataprocessing unit 100 in one embodiment may be pre-assembled as a singleintegrated unit with the analyte sensor 106 in electrical contact withthe data processing unit 101, and further, where a portion of theanalyte sensor 106 is disposed within the lower portion 102B of theintroducer such that, the user or patient may easily, and accuratelyposition the analyte sensor 106 under the skin layer to establish fluidcontact with the patient's analyte, and thereafter, to provide thedetected analyte levels from the analyte sensor 106 to the dataprocessing unit 101.

FIG. 6 illustrates a block diagram of an analyte monitoring system withintegrated analyte sensor delivery and data processing unit inaccordance with one embodiment of the present invention. Referring toFIG. 6, a data monitoring and management system 600 such as, forexample, an analyte (e.g., glucose) monitoring and management system inaccordance with one embodiment of the present invention is shown. Thesubject invention is further described primarily with respect to aglucose monitoring system for convenience and such description is in noway intended to limit the scope of the invention. It is to be understoodthat the analyte monitoring system may be configured to monitor avariety of analytes, e.g., lactate, and the like.

Analytes that may be monitored include, for example, acetyl choline,amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase(e.g., CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growthhormones, hormones, ketones, lactate, peroxide, prostate-specificantigen, prothrombin, RNA, thyroid stimulating hormone, and troponin.The concentration of drugs, such as, for example, antibiotics (e.g.,gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs ofabuse, theophylline, and warfarin, may also be monitored.

The data monitoring and management system 600 in one embodiment includesan integrated analyte sensor and data processing unit 610, a dataanalysis unit 630 which is configured to communicate with the integratedanalyte sensor and data processing unit 610 via a communication link620. The data analysis unit 630 may be further configured to transmitand/or receive data to and/or from a data processing terminal 650 viacommunication link 640. The data processing terminal 650 in oneembodiment may be configured for evaluating the data received by thedata analysis unit 630.

Referring again to FIG. 6, also shown is a fluid delivery unit 670 whichis operatively coupled to the data processing terminal 650 viacommunication link 680, and further operatively coupled to the dataanalysis unit 630 via communication link 660, and also, operativelycoupled to the integrated analyte sensor and data processing unit 610via communication link 690. In one embodiment, the fluid delivery unit670 may include an external or implantable infusion device such as aninsulin infusion pump, or the like, which may be configured toadminister insulin to patients, and which may be configured to determinesuitable modifications or updates to the medication dispensing profilebased on data received from one or more of the integrated analyte sensorand data processing unit 610, data analysis unit 630, or data processingterminal 650, for example, for administering and modifying basalprofiles, as well as for determining appropriate boluses foradministration based on, among others, the detected analyte levelsreceived from the integrated analyte sensor and data processing unit610.

Furthermore, referring again to FIG. 6, the one or more of thecommunication links 620, 640, 660, 680, and 690 may be configured as oneor more of a wired or a wireless communication link, for example,including but not limited to RS232 cable connection, a Universal SerialBus (USB) connection, an RF communication link, an infraredcommunication link, a Bluetooth® enabled communication link, an 802.11xwireless communication link, or an equivalent wireless communicationprotocol which would allow secure, wireless communication of severalunits (for example, per HIPAA requirements) while avoiding potentialdata collision and interference.

Moreover, it will be appreciated by one of ordinary skill in the artthat the data monitoring and management system 600 may include one ormore integrated analyte sensor and data processing unit 610, one or moredata analysis unit 630, one or more fluid delivery unit 670 and one ormore data processing terminal 650. In addition, the one or moreintegrated analyte sensor and data processing unit 610, one or more dataanalysis unit 630, one or more fluid delivery unit 670 and one or moredata processing terminal 650 may be in communication with a remote siteover a data network such as the internet for transmitting and/orreceiving information associated with the functions and operations ofeach device. For example, the one or more integrated analyte sensor anddata processing unit 610, one or more data analysis unit 630, one ormore fluid delivery unit 670 and one or more data processing terminal650 may be in communication with a data network such as the internet forretrieving and/or transmitting data from a remote server terminal.

Furthermore, in one embodiment, in a multi-component environment, eachdevice is configured to be uniquely identified by each of the otherdevices in the system so that communication conflict is readily resolvedbetween the various components within the data monitoring and managementsystem 100 of FIG. 1.

In one embodiment of the present invention, the sensor 106 of FIG. 2 isphysically positioned in or on the body of a user whose analyte level isbeing monitored. The sensor 106 may be configured to continuously samplethe analyte level of the user and convert the sampled analyte level intoa corresponding data signal for transmission by the data processing unit101 of FIG. 1. More specifically, in one embodiment, the data processingunit 101 may be configured to perform data processing such as filteringand encoding of data signals, each of which corresponds to a sampledanalyte level of the user, for transmission to the data analysis unit630 via the communication link 620.

In one embodiment, the communication link 620 may be configured as aone-way RF communication path from the integrated analyte sensor anddata processing unit 610 to the data analysis unit 630. In suchembodiment, the data processing unit 101 of the integrated analytesensor and data processing unit 610 is configured to transmit thesampled data signals received from the sensor 106 withoutacknowledgement from the data analysis unit 630 that the transmittedsampled data signals have been received. For example, the dataprocessing unit 101 may be configured to transmit the encoded sampleddata signals at a fixed rate (e.g., at one minute intervals) after thecompletion of the initial power on procedure. Likewise, the dataanalysis unit 630 may be configured to detect the encoded sampled datasignals transmitted from the data processing unit 101 at predeterminedtime intervals. Alternatively, the communication link 620 may beconfigured with a bi-directional RF (or otherwise) communication betweenthe data processing unit 101 and the data analysis unit 630.

Referring again to FIG. 6, in one embodiment, the data processingterminal 650 may include a personal computer, a portable computer suchas a laptop or a handheld device (e.g., personal digital assistants(PDAs)), and the like, each of which may be configured for datacommunication with the receiver via a wired or a wireless connection.Additionally, the data processing terminal 650 may further be connectedto a remote data network such as over the internet (not shown) forstoring, retrieving and updating data corresponding to the detectedanalyte level of the user and/or therapy related information such asmedication delivery profiles prescribed by a physician, for example.

FIG. 7 illustrates a block diagram of the data processing unit of theintegrated analyte sensor delivery and data processing unit 610 inaccordance with one embodiment of the present invention. Referring toFIGS. 6 and 7, the data processing unit 610 in one embodiment includesan analog interface 701 configured to communicate with the sensor 106(FIG. 2), a user input 702, and a temperature detection section 703,each of which is operatively coupled to a data processing unit processor704 such as one or more central processing units (CPUs) or equivalentmicroprocessor units.

Further shown in FIG. 7 are a transmitter serial communication section705 and an RF transceiver 706, each of which is also operatively coupledto the processor 704. In one embodiment, the serial communicationsection 705 may be operatively coupled to the analog interface 701 viacommunication link 709. Moreover, a power supply 707 such as a batteryis also provided in the data processing unit 610 to provide thenecessary power for the components in the data processing unit 610.Additionally, as can be seen from the figure, clock 708 is provided to,among others, supply real time information to the processor 704.

Referring back to FIG. 7, the power supply section 707 in one embodimentmay include a rechargeable battery unit that may be recharged by aseparate power supply recharging unit (for example, provided in the dataanalysis unit 630 (FIG. 6)) so that the data processing unit 101 may bepowered for a longer period of usage time. In addition, the temperaturemeasurement (or detection) section 703 of the data processing unit 610is configured to monitor the temperature of the skin near the sensorinsertion site. The temperature reading may be used to adjust theanalyte readings obtained from the analog interface 701.

In this manner, in one embodiment, the sensor detected analyte levelsare provided to the data processing unit of the integrated analytesensor and data processing unit 610 (FIG. 6), for example, as currentsignals, and which are in turn, converted to respective digital signalsfor transmission (including, for example, RF transmission) to the dataanalysis unit 630, fluid delivery unit 670, and/or the data processingterminal 650 of FIG. 6 for further processing and analysis (includingdrug (e.g., insulin) therapy management, infusion control, and healthmonitoring and treatment, for example). That is, the monitored analytedata may be used by the patient and/or the patient's healthcare providerto modify the patient's therapy such as an infusion protocol (such asbasal profile modifications in the case of diabetics) as necessary toimprove insulin infusion therapy for diabetics, and further, to analyzetrends in analyte levels for improved treatment.

Additional detailed description of the data monitoring and managementsystem such as analyte monitoring systems, its various componentsincluding the functional descriptions of data processing unit and dataanalysis unit are provided in U.S. Pat. No. 6,175,752 issued Jan. 16,2001 entitled “Analyte Monitoring Device and Methods of Use”, and inU.S. Pat. No. 7,811,231 issued Oct. 12, 2010 entitled “ContinuousGlucose Monitoring System and Methods of Use”, each assigned to theAssignee of the present application.

In the manner described above, in one embodiment, the integrated analytesensor and data processing unit assembly is configured to integrate ananalyte sensor, a sensor introducer mechanism, and a data processingdevice into a single disposable assembly which allows for simple andaccurate sensor deployment to the desired subcutaneous position, andwhich may be used with one hand by the user or the patient. Accordingly,a separate sensor introducing device such as a separate insertion gun ora separate sensor delivery mechanism is not necessary.

Furthermore, by integrating the analyte sensor, the introducer as wellas the data processing unit into a single assembly, it is possible tohave a smaller profile, simpler use application with less packagingthereby achieving cost reduction in manufacturing. Indeed, by reducingthe number of components needed for sensor placement, within the scopeof the present invention, other benefits such as reduction in materialcost, weight, packaging, and associated handling and disposal may beachieved.

An apparatus including an analyte sensor and a data processing unit inaccordance with one embodiment of the present invention includes ahousing, a data processing unit coupled to the housing, an introducerremovably coupled to the housing, the introducer including a firstportion configured for piercing through a skin layer of a subject, andan analyte sensor coupled to the housing, the analyte sensor including afirst portion and a second portion, the first portion of the analytesensor coupled to the first portion of the introducer, and the secondportion of the analyte sensor coupled to the data processing unit, wherethe first portion of the analyte sensor is configured for transcutaneousplacement so as to be in fluid contact with an interstitial fluid of thesubject, where the second portion of the analyte sensor is in electricalcontact with the data processing unit, and further, where at least aportion of the data processing unit, at least a portion of theintroducer and at least a portion of the analyte sensor are coupled tothe housing as a single integrated assembly.

In one embodiment, there is further provided an adhesive layersubstantially on a lower surface of the housing, the adhesive layerconfigured to removably attach the housing to the skin layer of thesubject.

Additionally, a guard segment may be removably coupled to the firstportion of the introducer, where the guard segment may be configured tosubstantially seal the first portion of the introducer.

In a further aspect, the first portion of the introducer may include asharp tip for piercing through the skin layer of the subject, whereinwhen the sharp tip is pierced through the skin layer, the first portionof the analyte sensor is transcutaneously placed under the skin layer ofthe subject so as to be in fluid contact with the interstitial fluid ofthe subject.

In another aspect, the introducer may be configured to decouple from thehousing after the first portion of the analyte sensor istranscutaneously positioned under the skin layer of the subject.

The analyte sensor may include a glucose sensor.

The data processing unit in one embodiment may include a datatransmission unit configured to receive one or more signals associatedwith an analyte level of the subject from the analyte sensor, where thedata transmission unit may be configured to wirelessly transmit dataassociated with the one or more signals received from the analytesensor, where the data transmission unit may include an RF datatransmission unit.

An integrated assembly in accordance with another embodiment of thepresent invention includes a housing, a data processing unitsubstantially disposed within the housing, an introducer removablycoupled to the housing, at least a portion of the introducer disposedwithin the housing, and an analyte sensor coupled to the housing, afirst portion of the analyte sensor configured for subcutaneousplacement and in fluid contact with an interstitial fluid of a subject,and a second portion of the analyte sensor disposed within the housingand in electrical communication with the data processing unit.

The second portion of the analyte sensor in one embodiment may bepermanently coupled to the data processing unit.

In another aspect, the introducer may be configured to decouple from thehousing after the second portion of the analyte sensor istranscutaneously positioned under the skin layer of the subject.

An insertion kit in accordance with still another embodiment includes ahousing, a data processing unit substantially disposed within thehousing, an introducer removably coupled to the housing, at least aportion of the introducer disposed within the housing, and an analytesensor coupled to the housing, a first portion of the analyte sensorconfigured for subcutaneous placement and in fluid contact with aninterstitial fluid of a subject, and a second portion of the analytesensor disposed within the housing and in electrical communication withthe data processing unit.

In one embodiment, the introducer may be manually removed from thehousing.

Various other modifications and alterations in the structure and methodof operation of this invention will be apparent to those skilled in theart without departing from the scope and spirit of the invention.Although the invention has been described in connection with specificpreferred embodiments, it should be understood that the invention asclaimed should not be unduly limited to such specific embodiments. It isintended that the following claims define the scope of the presentinvention and that structures and methods within the scope of theseclaims and their equivalents be covered thereby.

1-18. (canceled)
 19. An apparatus, comprising: an introducer including alower portion having a sharp distal end configured for piercing througha skin layer; an analyte sensor; and a guard segment for the analytesensor and the introducer.
 20. The apparatus of claim 19, wherein theguard segment is configured to substantially cover the lower portion ofthe introducer and a lower portion of the analyte sensor.
 21. Theapparatus of claim 20, wherein the lower portion of the analyte sensoris disposed within the lower portion of the introducer.
 22. Theapparatus of claim 19, wherein the guard segment is configured tomaintain the lower portion of the introducer and the analyte sensor in asubstantially sterile environment.
 23. The apparatus of claim 19,wherein the guard segment is configured to be removed from the lowerportion of the introducer prior to placement of the sharp distal end anda portion of the analyte sensor through the skin layer.
 24. Theapparatus of claim 19, further comprising a data processing unit,wherein the data processing unit includes an aperture through which theintroducer and the analyte sensor pass.
 25. The apparatus of claim 24,wherein the aperture comprises a self-sealing aperture.
 26. Theapparatus of claim 24, wherein the guard segment comprises a proximalend and a distal end, wherein the proximal end of the guard segment isadjacent to a bottom surface of the data processing unit.
 27. Theapparatus of claim 26, wherein the distal end of the guard segmentcovers the sharp distal end of the introducer.
 28. The apparatus ofclaim 26, further comprising an adhesive patch, wherein the adhesivepatch includes an opening through which the introducer and the analytesensor pass.
 29. The apparatus of claim 28, wherein the opening of theadhesive patch and the aperture of the data processing unit aresubstantially aligned.
 30. The apparatus of claim 29, wherein theproximal end of the guard segment is adjacent to the aperture of thedata processing unit and the opening of the adhesive patch.
 31. Theapparatus of claim 24, wherein the analyte sensor comprises a lowerportion and an upper portion, wherein the lower portion of the analytesensor is disposed within the lower portion of the introducer, andwherein the guard segment is configured to substantially cover the lowerportion of the introducer.
 32. The apparatus of claim 31, wherein theupper portion of the analyte sensor is disposed in the data processingunit.
 33. The apparatus of claim 31, wherein the upper portion of theanalyte sensor includes an upper segment that is perpendicular to thelower portion of the analyte sensor.
 34. The apparatus of claim 33,wherein the upper segment of the analyte sensor is not covered by theguard segment.
 35. The apparatus of claim 19, wherein the guard segmentcomprises a substantially cylindrical shape.
 36. The apparatus of claim26, wherein the proximal end of the guard segment includes a top portionhaving a first diameter, wherein the distal end of the guard segmentcomprises a second diameter, and wherein the first diameter is greaterthan the second diameter.
 37. The apparatus of claim 19, furthercomprising a data processing unit, and wherein the analyte sensor, theintroducer, and the data processing unit form an integrated assembly inwhich at least the analyte sensor and the introducer are maintained in asubstantially sterile environment.
 38. The apparatus of claim 36,wherein the top portion of the guard segment comprises a flangeconfigured to interface with the bottom surface of the data processingunit.